TUmor-volume to breast-volume RAtio for improving COSmetic results in breast cancer patients (TURACOS); a randomized controlled trial.

BACKGROUND: Cosmetic result following breast conserving surgery (BCS) for cancer influences quality of life and psychosocial functioning in breast cancer patients. A preoperative prediction of expected cosmetic result following BCS is not (yet) standard clinical practice and therefore the choice for either mastectomy or BCS is still subjective. Recently, we showed that tumour volume to breast volume ratio as well as tumour location in the breast are independent predictors of superior cosmetic result following BCS. Implementation of a prediction model including both factors, has not been studied in a prospective manner. This study aims to improve cosmetic outcome by implementation of a prediction model in the treatment decision making for breast cancer patients opting for BCS. METHODS/DESIGN: Multicentre, single-blinded, randomized controlled trial comparing standard preoperative work-up to a preoperative work-up with addition of the prediction model. Tumour volume to breast volume ratio and tumour location in the breast will be used to predict cosmetic outcome in invasive breast cancer patients opting for BCS. Three dimensional (3D)-ultrasonography will be used to measure the tumour volume to breast volume ratio needed for the prediction model. Sample size was estimated based on a 14% improvement in incidence of superior cosmetic result one year after BCS (71% in the control group versus 85% in the intervention group). Primarily cosmetic outcome will be evaluated by a 6-member independent panel. Secondary endpoints include; (1) patient reported outcome measured by BREAST-Q, EORTC-QLQ-C30/BR23 and EQ-5D-5 L (2) cosmetic outcome as assessed through the BCCT.core software, (3) radiation-induced reaction (4) surgical treatment performed, (5) pathological result and (6) cost-effectiveness. Follow-up data will be collected for 3 years after surgery or finishing radiotherapy. DISCUSSION: This randomized controlled trial examines the value of a preoperative prediction model for the treatment-decision making. It aims for a superior cosmetic result in breast cancer patients opting for BCS. We expect improvement of patients' quality of life and psychosocial functioning in a cost-effective way. TRIAL REGISTRATION: Prospectively registered, February 17th 2015, at 'Nederlands Trialregister - NTR4997 '.

A prospective validation study of sentinel lymph node biopsy in multicentric breast cancer: SMMaC trial.

BACKGROUND: Multicentric breast cancer is often considered a contra-indication for sentinel lymph node (SLN) biopsy due to concerns with sensitivity and false negative rate. To assess SLN feasibility and accuracy in multicentric breast cancer, the multi-institutional SMMaC trial was conducted. METHODS: In this study 30 patients with multicentric breast cancer and a clinically negative axilla were prospectively included. Periareolar injection of radioisotope and blue dye was administered. In all patients SLN biopsy was validated by back-up completion axillary lymph node dissection. RESULTS: the SLN was successfully identified in 30 of 30 patients (identification rate 100%). The incidence of axillary metastases was 66.7% (20/30). The false negative rate was 0% (0/20) and the sensitivity was 100% (20/20). The negative predictive value was 100% (10/10). CONCLUSION: SLN biopsy in multicentric breast cancer seems feasible and accurate and should therefore be considered in patients with multicentric breast cancer and clinically negative axilla.

Efficacy of 'radioguided occult lesion localisation' (ROLL) versus 'wire-guided localisation' (WGL) in breast conserving surgery for non-palpable breast cancer: a randomised controlled multicentre trial.

For the management of non-palpable breast cancer, accurate pre-operative localisation is essential to achieve complete resection with optimal cosmetic results. Radioguided occult lesions localisation (ROLL) uses the radiotracer, injected intra-tumourally for sentinel lymph node identification to guide surgical excision of the primary tumour. In a multicentre randomised controlled trial, we determined if ROLL is superior to the standard of care (i.e. wire-guided localisation, WGL) for preoperative tumour localisation. Women (>18 years.) with histologically proven non-palpable breast cancer and eligible for breast conserving treatment with sentinel node procedure were randomised to ROLL or WGL. Patients allocated to ROLL received an intra-tumoural dose of 120 Mbq technetium-99 m nanocolloid. The tumour was surgically removed, guided by gamma probe detection. In the WGL group, ultrasound- or mammography-guided insertion of a hooked wire provided surgical guidance for excision of the primary tumour. Primary outcome measures were the proportion of complete tumour excisions (i.e. with negative margins), the proportion of patients requiring re-excision and the volume of tissue removed. Data were analysed according to intention-to-treat principle. This study is registered at ClinincalTrials.gov, number NCT00539474. In total, 314 patients with 316 invasive breast cancers were enrolled. Complete tumour removal with negative margins was achieved in 140/162 (86 %) patients in the ROLL group versus 134/152 (88 %) patients in the WGL group (P = 0.644). Re-excision was required in 19/162 (12 %) patients in the ROLL group versus 15/152 (10 %) (P = 0.587) in the WGL group. Specimen volumes in the ROLL arm were significantly larger than those in the WGL arm (71 vs. 64 cm(3), P = 0.017). No significant differences were seen in the duration and difficulty of the radiological and surgical procedures, the success rate of the sentinel node procedure, and cosmetic outcomes. In this first multicentre randomised controlled comparison of ROLL versus WGL in patients with histologically proven breast cancer, ROLL is comparable to WGL in terms of complete tumour excision and re-excision rates. ROLL, however, leads to excision of larger tissue volumes. Therefore, ROLL cannot replace WGL as the standard of care.

The influence of mechanical bowel preparation in elective colorectal surgery for diverticulitis.

BACKGROUND: Mechanical bowel preparation (MBP) has been shown to have no influence on the incidence of anastomotic leakage in overall colorectal surgery. The role of MBP in elective surgery in combination with an inflammatory component such as diverticulitis is yet unclear. This study evaluates the effects of MBP on anastomotic leakage and other septic complications in 190 patients who underwent elective surgery for colonic diverticulitis. METHODS: A subgroup analysis was performed in a prior multicenter (13 hospitals) randomized trial comparing clinical outcome of MBP versus no MBP in elective colorectal surgery. Primary endpoint was the occurrence of anastomotic leakage in patients operated on for diverticulitis, and secondary endpoints were septic complications and mortality. RESULTS: Out of a total of 1,354 patients, 190 underwent elective colorectal surgery (resection with primary anastomosis) for (recurrent or stenotic) diverticulitis. One hundred and three patients underwent MBP prior to surgery and 87 did not. Anastomotic leakage occurred in 7.8 % of patients treated with MBP and in 5.7 % of patients not treated with MBP (p = 0.79). There were no significant differences between the groups in septic complications and mortality. CONCLUSION: Mechanical bowel preparation has no influence on the incidence of anastomotic leakage, or other septic complications, and may be safely omitted in case of elective colorectal surgery for diverticulitis.

Continuous cerebral compliance monitoring in severe head injury: its relationship with intracranial pressure and cerebral perfusion pressure.

BACKGROUND: Cerebral compliance expresses the capability to buffer an intracranial volume increase while avoiding a rise in intracranial pressure (ICP). The autoregulatory response to Cerebral Perfusion Pressure (CPP) variation influences cerebral blood volume which is an important determinant of compliance. The direction of compliance change in relation to CPP variation is still under debate. The aim of the study was to investigate the relationship between CPP and compliance in traumatic brain injured (TBI) patients by a new method for continuous monitoring of intracranial compliance as used in neuro-intensive care (NICU). METHOD: Three European NICU's standardised collection of CPP, compliance and ICP data to a joint database. Data were analyzed using an unpaired student t-test and a multi-level statistical model. RESULTS: For each variable 108,263 minutes of data were recorded from 21 TBI patients (19 patients GCS/=20 mmHg in 20% and CPP<60 mmHg for 10.7% of the time. Compliance was lower (0.51+/-0.34 ml/mmHg) at ICP>/=20 than at ICP<20 mmHg (0.73+/-0.37 ml/mmHg) (p<0.0001). Compliance was significantly lower at CPP<60 than at CPP>/=60 mmHg: 0.56+/-0.36 and 0.70+/-0.37 ml/mmHg respectively (p<0.0001). The CPP - compliance relationship was different when ICP was above 20 mmHg compared with below 20 mmHg. At ICP<20 mmHg compliance rose as CPP rose. At ICP>/=20 mmHg, the relation curve was convexly shaped. At low CPP, the compliance was between 0.20 and 0.30 ml/mmHg. As the CPP reach 80 mmHg average compliance was 0.55 ml/mmHg., but compliance fell to 0.40 ml/mmHg when CPP was 100 mmHg. CONCLUSIONS: Low CPP levels are confirmed to be detrimental for intracranial compliance. Moreover, when ICP was pathological, indicating unstable intracranial equilibrium, a high CPP level was also associated with a low volume-buffering capacity.

The BrainIT Group: concept and current status 2004.

INTRODUCTION: An open collaborative international network has been established which aims to improve inter-centre standards for collection of high-resolution, neurointensive care data on patients with traumatic brain injury. The group is also working towards the creation of an open access, detailed and validated database that will be useful for hypothesis generation. In Part A, we describe the underlying concept of the group and it's aims and in Part B we describe the current status of the groups development. METHODS: Four group meetings funded by the EEC have enabled definition of a "Core Dataset" to be collected from all centres regardless of specific project aim. A form based feasibility study was conducted and a prospective data collection exercise of core data using PC and hand held computer based methods is in progress. FINDINGS: A core-dataset was defined and can be downloaded from the BrainIT web-site (go to "Core dataset" link at: www.brainit.org). A form based feasibility study was conducted showing the overall feasibility for collection of the core data elements was high. Software tools for collection of the core dataset have been developed. Currently, 130 patient's data from 16 European centres have been recruited to the joint database as part of an EEC funded proof of concept study. INTERPRETATION: The BrainIT network provides a more standardised and higher resolution data collection mechanism for research groups, organisations and the device industry to conduct multicentre trials of new health care technology in patients with traumatic brain injury.

Accurate data collection for head injury monitoring studies: a data validation methodology.

BACKGROUND: BrainIT is a multi centre, European project, to collect high quality continuous data from severely head injured patients using a previously defined [6] core data set. This includes minute-by-minute physiological data and simultaneous treatment and management information. It is crucial that the data is correctly collected and validated. METHODS: Minute-by-minute physiological monitoring data is collected from the bedside monitors. Demographic and clinical information, intensive care management and secondary insult management data, are collected using a handheld computer. Data is transferred from the handheld device to a local computer where it is reviewed and anonymised before being sent electronically, with the physiological data, to the central database in Glasgow. Automated computer tools highlight missing or ambiguous data. A request is then sent to the contributing centre where the data is amended and returned to Glasgow. Of the required data elements 20% are randomly selected for validation against original documentation along with the actual number of specific episodic events during a known period. This will determine accuracy and the percentage of missing data for each record. CONCLUSION: Advances in patient care require an improved evidence base. For accurate, consistent and repeatable data collection, robust mechanisms are required which should enhance the reliability of clinical trials, assessment of management protocols and equipment evaluations.

Survey of traumatic brain injury management in European Brain-IT centres year 2001.

BACKGROUND: The aim of this study was to obtain basic knowledge about the current local conditions and neurointensive care of traumatic brain injury (TBI) in the new multi-centre collaborative BrainIT group. MATERIALS AND METHODS: The survey comprised a background part on local policies (Part A), and a case study section (Part B). The information was gathered by questionnaire followed by telephone interviews. Twenty-three BrainIT centres participated in the survey and answers from two respondents were available from 18 of the sites. RESULTS: The average proportion of agreement between duplicate respondents was 0.778 (range 0.415-1.00). All BrainIT centres monitored ICP. The treatment protocols seem to have a pattern concerning escalation of treatment of intracranial hypertension: 1/ evacuation of mass lesions and head elevation; 2/ increased sedation and mannitol; 3/ hyperventilation; 4/ ventricular drainage; 5/ craniectomy and barbituates. CONCLUSIONS: There seemed to be an agreement on neurointensive care policies within the BrainIT group. The suggested order of treatment was generally in accordance with published guidelines although the suggested order and combinations of different treatments varied. Variation of treatment within the range of prescribed standards provides optimal conditions for an interesting future analysis of treatment and monitoring data in reality using the BrainIT database.

Assessment of different data representations and averaging methods on the Spiegelberg compliance device.

The Spiegelberg Compliance Device (Spiegelberg KG, Hamburg, Germany) has been available for the automated measurement and calculation of minute by minute intracranial compliance. Widespread practical use has been somewhat limited by the instability of values: especially at low intracranial pressures. We looked at two aspects of a methodology in an attempt to increase the value of the Spiegelberg device in the clinical setting. Firstly, we discussed the difference in representing measured values as elastance (dp/dv) instead of compliance (dv/dp); and secondly we proposed the use of an averaging algorithm called the Exponentially Weighted Moving Average (ewma), which could be applied as a flexible method to follow trends and rapid changes in the elastance (or compliance). Clinical data from sixteen patients were gathered and statistical analysis was focused on three particular aspects, the coefficient of variation which indicates the variability of data values, the correlation between the elastance (or compliance) time series and the underlying ICP signal and the percentage of outliers greater than 2.5 standard deviations from the mean. Our results showed that expressing elastance (dp/dv) instead of compliance (dv/dp) yielded fewer outliers and had a better correlation to ICP, and the ewma method had a better correlation to ICP than the Spiegelberg method.

Bench test assessment of the new Raumedic Neurovent-P ICP sensor: a technical report by the BrainIT group.

BACKGROUND: In clinical practice, fiberberoptic and piezo-electric ICP probes are often used for measuring intracranial pressure (ICP). A number of similar technologies, although performing well in bench test studies, have been shown to exhibit unacceptable zero drift, fragility or both during trials conducted under clinical conditions. Recently, a new technology has become available, the Neurovent-P (Raumedic AG + CO, Raumedic, Germany). As a pre-requisite for a clinical trial, we have conducted and report on bench test studies to confirm the manufacturer's long term zero-drift performance for this technology. METHOD: In a test rig static tests (recording of 20 mmHg pressure) and dynamic tests, ranging from 5 to 50 mmHg have been performed. FINDINGS: 10 ICP probes have been tested for a total of 60 days. All the catheters, after the connection with the ICU monitor displayed a static pressure of 0 +/- 1 mmHg and did not required pre-insertion alteration. At five days, mean zero drift was 0.6 +/- 0.9 mmHg. Overall, zero drift ranged from 0 to 2 mmHg. At a fixed static pressure of 20 mmHg, the mean recorded value was 20.6 +/- 0.8 mmHg, ranging from 19 to 23 mmHg. A regression analysis of the relationship between the applied pressure and the recorded pressure during the dynamic tests of the 10 catheters yielded a correlation coefficient R2 of 0.997. Applying the Altman and Bland method to assess the bias and confidence limits for the Raumedic catheter responses during the dynamic tests against the applied gold-standard hydrostatic column pressures, the average bias of -0.66 +/- 0.85 mmHg, with 95% CLs of -2 mmHg and 1 mmHg. CONCLUSIONS: Mean zero drift, after five days, was very small and long-term continuous recording of a stable pressure was very precise. The response at dynamic tests, i.e. the changes of pressure in a wide range, was excellent. The average bias of the Raumedic catheter compared with the hydrostatic column is very small. After this bench test, the next and most critical step will be to conduct a trial of this promising technology under more demanding clinical environment.

A model for studies of intracranial volume pressure dynamics in traumatic brain injury.

The present study was undertaken to establish an experimental trauma model where it was possible to alter intracranial pressure (ICP) dynamics without raising intracranial pressure to abnormal levels and monitor metabolic disturbances with microdialysis. Thirty rats were intubated and mechanically ventilated before and after trauma. ICP was measured in the left ventricle. A weight-drop technique (21 g from 35 cm) with a brain compression of 1.5 mm was used to produce the injury. Intracranial compensatory volume was decreased 20 or 60 microL by placement of rubber film between the dura mater and bone. A bolus injection technique was used for the pressure volume response. ICP remained within normal limits for 2 h after trauma irrespective of the reduction in compensatory intracranial volume. Pressure-volume index decreased from 0.0825 +/- 0.009 to 0.0779 +/- 0.011 mL in the sham trauma and from 0.0871 +/- 0.018 to 0.0748 +/- 0.017 mL in the trauma groups (p < 0.015) when the intracranial volume was reduced by 60 microL. Intracranial compliance was not affected significantly. The present study shows that it is possible to vary ICP dynamics in a traumatic brain injury model without causing pathological increases in baseline ICP. This model may be used to study the effects of secondary insults (i.e., hypotension, hypoxia, hypercarbia, and hyperthermia) on the injured brain when ICP is normal but intracranial compensatory volume is impaired.

Clinical outcome after endovascular coil embolization in elderly patients with subarachnoid hemorrhage.

Subarachnoid hemorrhage (SAH) is not an unusual disease in an elderly population. The clinical outcome has improved over time. It has been suggested that elderly SAH patients would benefit from endovascular aneurysm treatment. The aim of this study was to evaluate technical results and clinical outcome in a series of elderly SAH-patients treated with endovascular coil embolization. Sixty-two patients (> or = 65 years) presenting with aneurysmal SAH underwent early endovascular coil embolization at Uppsala University Hospital between September 1996 and December 2000. In all 62 cases included in the study, endovascular coil embolization was considered the first line of treatment. Admission variables, specific information on technical success, degree of occlusion and procedural complications, and outcome figures were recorded. Clinical grade on admission was Hunt and Hess (H&H) I-II in 39%, H&H III in 27% and H&H IV-V in 34% of the patients. The proportion of posterior circulation aneurysms was 24%. Coil embolization was successfully completed in 94%. The degree of occlusion of the treated aneurysm was complete occlusion in 56%, neck remnant in 21%, residual filling in 11%, other remnant in 5% and not treated in 6%. The rate of procedural complications was 11%. Outcome after 6 months was favorable in 41%, severe disability in 36% and poor in 22%. Favorable outcome was achieved in 57% of the H&H I-II patients, 47% of the H&H III patients and 17% of the H&H IV-V patients. Endovascular aneurysm treatment can be performed in elderly patients with SAH with a high level of technical success, acceptable aneurysm occlusion results, an acceptable rate of procedural complications and fair outcome results.

R3-survey of traumatic brain injury management in European Brain IT centres year 2001.

OBJECTIVE: To obtain knowledge about the conditions and management of traumatic brain injury (TBI) in a collaborative network of Brain Information Technology centres. DESIGN: The Brain IT (Brain monitoring with Information Technology) survey comprised two parts: local conditions and policies (part A), and a case study part (part B). The information was gathered by written questionnaires followed by telephone interviews. PARTICIPANTS: Twenty-four Brain IT centres participated (two respondents from 18 sites). RESULTS: The average proportion of agreement between duplicate respondents was 0.79 (range 0.44-1.00). All Brain IT centres monitored ICP. The reported order of treatment for intracranial hypertension was: evacuation of mass-lesions and head elevation (1), increase of sedation and Mannitol scheme (2), hyperventilation (3), ventricular drainage (4), craniectomy and pentothal coma (5), and decompressive lobectomy (6). The respondents were less prone to evacuate expansive contusions in relation to extra cerebral hematomas. The most common suggested interventions (alone or in combination) for treatment of intracranial hypertension without mass lesions was the Mannitol scheme (included in 71% of the suggestions), CSF drainage (included in 56%), hyperventilation (included in 32%), and pentothal coma (included in 22%). CONCLUSIONS: The suggested management of TBI was mainly in accordance with published guidelines, although a minor proportion of the answers deviated to some extent. The suggested order and combinations of different treatment interventions varied. Variation of treatment within the range of prescribed standards provides optimal conditions for an interesting future analysis of treatment and monitoring data as collected prospectively in a Brain IT database.

The BrainIT group: concept and core dataset definition.

INTRODUCTION: An open collaborative international network has been established which aims to improve inter-centre standards for collection of high-resolution, neurointensive care data on patients with traumatic brain injury. The group is also working towards the creation of an open access, detailed and validated database that will be useful for post-hoc hypothesis testing. In Part A, the underlying concept, the group coordination structure, membership guidelines and database access and publication criteria are described. Secondly, in part B, we describe a set of meetings funded by the EEC that allowed us to define a "Core Dataset" and we present the results of a feasibility exercise for collection of this core dataset. METHODS: Four group meetings funded by the EEC have enabled definition of a "Core Dataset" to be collected from all centres regardless of specific project aim. A paper based pilot collection of data was conducted to determine the feasibility for collection of the core dataset. Specially designed forms to collect the core dataset demographic and clinical information as well as sample the time-series data elements were distributed by both email and standard mail to 22 BrainIT centres. A deadline of two months was set to receive completed forms back from centres. A pilot data collection of minute by minute physiological monitoring data was also performed. FINDINGS: A core-dataset was defined and can be downloaded from the BrainIT web-site (go to "Core dataset" link at: www.brainit.org). Eighteen centres (82%) returned completed forms by the set deadline. Overall the feasibility for collection of the core data elements was high with only 10 of the 64 questions (16%) showing missing data. Of those 10 fields with missing data, the average number of centres not responding was 12% and the median 6%. An SQL database to hold the data has been designed and is being tested. Software tools for collection of the core dataset have been developed. Ethics approval has been granted for collection of multi-centre data as part of a pilot data collection study. INTERPRETATION: The BrainIT network provides a more standardised and higher resolution data collection mechanism for research groups, organisations and the device industry to conduct multi-centre trials of new health care technology in patients with traumatic brain injury.

Clinical experience of prophylactic mastectomy followed by immediate breast reconstruction in women at hereditary risk of breast cancer (HB(O)C) or a proven BRCA1 and BRCA2 germ-line mutation.

AIM: Women with a proven BRCA1 or BRCA2 germ-line mutation or with a 50% risk of carrying the mutation, have an increased risk of breast cancer. Regular surveillance, chemoprevention or prophylactic mastectomy (PM) are options to detect breast cancer at an early stage or to reduce the risk. We describe the management of women who have opted for PM, the postoperative complications of PM, especially in combination with immediate breast reconstruction (IBR), and the oncological follow-up. METHODS: The medical records of all women who underwent a PM from December 1993 to December 1999 have been reviewed with respect to management, patient characteristics, complications and oncological follow-up. RESULTS: During the study period 112 women with a median age of 38.8 years opted for a PM: 76 were germline mutation carriers. After PM, 79 women without breast or ovarian cancer in their medical history, were free of disease after 2.5 years (median). Before PM, 29 women had been treated for breast cancer, 3.9 years (median) previously; 5 of these women had developed metastatic disease by the last consultation. Before PM, 2 patients had been treated for DCIS and 2 patients for ovarian cancer. Four DCIS were found; none of these women had evidence of disease 4.0 years (median) after PM. In 59 women laparoscopic prophylactic bilateral oophorectomy (PBO) was performed; 36 simultaneously with PM and 23 separately. A total of 103 women (92%) opted for IBR. After PM, the complication rate for IBR was 21%: 11% within 6 weeks and 10% at long-term follow-up (median 3.5) after PM, including the removal of 10 prostheses. CONCLUSIONS: Women with an increased risk of breast cancer due to a genetic predisposition should be adequately informed about the different treatment options in the setting of a multidisciplinary approach. PM can simultaneously be combined with PBO and IBR. IBR can facilitate the decision to undergo a PM. PM followed by IBR has an acceptable complication rate.

Multi-centre assessment of the Spiegelberg compliance monitor: interim results.

Analyses of a multi-centre database of 71 patients at risk of raised ICP showed that in head injured patients (n = 19) and tumour patients (n = 13) clear inverse relationships of ICP vs compliance exist. SAH patients (n = 5) appear to exhibit a biphasic relationship between ICP and compliance, however greater numbers of patients need to be recruited to this group. Patients with hydrocephalus (n = 34) show an initial decrease in compliance while ICP is less than 20 mmHg, thereafter compliance does not show a dependence upon ICP. A power analysis confirmed that sufficient numbers of patients have been recruited in the hydrocephalus group and a ROC analysis determined that a mean compliance value of 0.809 (lower and upper 95% CL = 0.725 & 0.894 resp.) was a critical threshold for raised ICP greater than 10 mmHg. Preliminary time-series analyses of the ICP and compliance data is revealing evidence that the cumulative time compliance is in a low compliance state (< 0.5 ml/mmHg), as a proportion of total monitoring time, increases more rapidly than the cumulative time ICP is greater than 25 mmHg. Before trials testing compliance thresholds can be designed, we need to consider not just the absolute threshold, but the duration of time spent below threshold. A survey may be required to identify a consensus of what is the minimum duration of raised ICP above 25 mmHg needed to instigate treatment.

Clinical experience in the use of the Spiegelberg automated compliance device in the assessment of patients with hydrocephalus.

Deciding upon shunting in patients with hydrocephalus with possibly related symptomatology, is difficult. The Spiegelberg automated device allows continuous measurements of intracranial compliance. We aimed to evaluate the added information that this new technology can provide, in addition to standard continuous ICP monitoring. Thirty-three patients with hydrocephalus were continuously monitored for ICP and compliance. Patients with abnormal ICP or compliance profiles were selected for shunting. Thirteen patients underwent ventriculo-peritoneal shunting on this basis, with 12 obtaining benefit and one dying as a complication of shunt-related sepsis. The 13 patients undergoing shunting had abnormalities in either intracranial pressure or compliance or both. Only 1 patient had normal ICP, but abnormal compliance and so the true complementary role of continuous compliance measurements cannot be determined. It is proposed that further recruitment be on a larger multi-centre basis. Determination of benefit is required, particularly as a possible time lag of abnormal ICP abnormal compliance over appearing during monitoring can be demonstrated.

A prospective study on silicone breast implants and the silicone-related symptom complex.

This cohort study prospectively evaluated the prevalence of the silicone-related symptom complex (SRSC) in relation to antinuclear antibodies (ANA) and magnetic resonance imaging (MRI) of silicone breast implants (SBI) 1 year after implantation. A total of 57 women undergoing mastectomy followed by immediate breast reconstruction (IBR) and SBI between March 1995 and March 1997 at the University Hospital Rotterdam/Daniel den Hoed Cancer Centre, were prospectively evaluated. Just before and 1 year after IBR the sera of these women were tested for the presence of ANA and they were screened for the prevalence of SRSC-related symptoms by questionnaire. All prostheses were evaluated by MRI 1 month and 1 year after IBR. Just before operation 11% of the women had a Sjögren score of more than 2, whereas 30% had such a score 1 year after IBR ( P = 0.01). One year postoperatively women had significantly more RA/Raynaud-related complaints: 21% preoperatively versus 40% 1 year after IBR ( P = 0.03). Within the undefined complaints-related group 19% had a score of 2 or more preoperatively and 33% 1 year after IBR ( P = 0.09). There were no new cases of ANA positivity 1 year after IBR. The linguine sign was seen by MRI in three implants: one 1 month after IBR and two 1 year after IBR. There was no relation to changes in SRSC expression and these MRI findings. In conclusion, 1 year after SBI implantation women had more SRSC-related complaints, especially Sjögren's and RA/Raynaud's. Moreover there was no correlation between elevated SRSC expression and changes in the presence of ANA or changes in MRI of the SBI 1 year after IBR.

Changes in intervention and outcome in elderly patients with subarachnoid hemorrhage.

BACKGROUND AND PURPOSE: The elderly constitute a significant and increasing proportion of the population. The aim of this investigation was to study time trends in clinical management and outcome in elderly patients with subarachnoid hemorrhage. METHODS: Two hundred eighty-one patients >/=65 years of age with aneurysmal subarachnoid hemorrhage who were accepted for treatment at the Uppsala University Hospital neurosurgery clinic during 1981 to 1998 were included. Hunt and Hess grades on admission, specific management components, and clinical outcomes were recorded. Three periods were compared: A, 1981 to 1986 (before neurointensive care); B, 1987 to 1992; and C, 1993 to 1998. RESULTS: The volume of elderly patients (>/=65 years of age) increased with time, especially patients >/=70 years of age. Furthermore the proportion of patients with more severe clinical conditions increased. A greater proportion of patients had a favorable outcome (A, 45%; B, 61%; C, 58%) despite older ages and more severe neurological and clinical conditions. In period C, Hunt and Hess I to II patients had a favorable outcome in 85% of cases compared with 64% in period A. This was achieved without any increase in the number of severely disabled patients. CONCLUSIONS: Elderly patients with subarachnoid hemorrhage can be treated successfully, and results are still improving. The introduction of neurointensive care may have contributed to the improved outcome without increasing the proportion of severely disabled patients. A defeatist attitude toward elderly patients with this otherwise devastating disease is not justified.

Adult respiratory distress syndrome: a complication of induced hypertension after severe head injury.

OBJECT: The factors involved in the development of adult respiratory distress syndrome (ARDS) after severe head injury were studied. The presence of ARDS complicates the treatment of patients with severe head injury, both because hypoxia causes additional injury to the brain and because therapies that are used to protect the lungs and improve oxygenation in patients with ARDS can reduce cerebral blood flow (CBF) and increase intracranial pressure (ICP). In a recent randomized trial of two head-injury management strategies (ICP-targeted and CBF-targeted), a fivefold increase in the incidence of ARDS was observed in the CBF-targeted group. METHODS: Injury severity, physiological data, and treatment data in 18 patients in whom ARDS had developed were compared with the remaining 171 patients in the randomized trial in whom it had not developed. Logistic regression analysis was used to study the interaction of the factors that were related to the development of ARDS. In the final exact logistic regression model, several factors were found to be significantly associated with an increased risk of ARDS: administration of epinephrine (5.7-fold increased risk), administration of dopamine in a larger than median dose (10.8-fold increased risk), and a history of drug abuse (3.1-fold increased risk). CONCLUSIONS: Although this clinical trial was not designed to study the association of management strategy and the occurrence of ARDS, the data strongly indicated that induced hypertension in this high-risk group of patients is associated with the development of symptomatic ARDS.